New drug combo takes on Hard-to-Treat cancers in first human test

NCT ID NCT06131398

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Aug 12, 2026 · Updated 4 times

Summary

This early-stage trial is testing an experimental drug called AMG 355, given alone or together with the immunotherapy Keytruda, in 77 adults with advanced solid tumors (like lung, colon, stomach, or melanoma) that have not responded to standard treatments. The main goals are to check safety, find the right dose, and look for early signs that the tumors shrink. Because it's a Phase 1 study, the focus is on safety and dosing, not yet on proving the drug works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: AMG 355 (an experimental drug) and pembrolizumab (Keytruda, an immunotherapy)
What this could lead to: If it works, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong: This is a very early Phase 1 trial with only 77 participants, so the main goal is safety and dosing — not yet proving the drug works. Many experimental cancer drugs fail in early testing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

77 people

The number who actually took part.

Started

Mar 2024

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Age ≥ 18 years at the time of signing informed consent. * Participants with histologically or cytologically confirmed metastatic or locally advanced solid tumors who have relapsed after and/or are refractory to or ineligible for established and available therapies with known clinical benefit at time of pre-screening: * Group A: NSCLC, CRC, GC, and melanoma. * Group B: NSCLC, CRC, GC. * Eastern Cooperative Oncology Group Performance status 0 or 1. * Life expectancy of \> 3 months, in the opinion of the investigator. * At least 1 measurable lesion as defined by modified RECIST 1.1 guidelines. Note: this lesion should be avoided for the required biopsies on the study. * Participants must be willing to undergo 1 or more biopsies as follows: * Fresh biopsy prior to enrollment is preferred or, if fresh tissue is not obtainable, an archival tumor sample may be acceptable if the sample was obtained within 6 months of enrollment and participant has not received any other treatment since sample was obtained, consult the Medical Monitor. * Mandatory fresh biopsy during cycle 2 (before the restaging of CT-scan) of treatment with AMG 355 (± pembrolizumab). Note: Where slides are accepted, samples must consist of a minimum of 11 (21 preferred) freshly-cut, serially, sectioned, unstained slides. A formalin-fixed, paraffin embedded block is preferred if available, but in lieu of a block, unstained slides or fresh wet tissue is acceptable. Key Exclusion Criteria: * Participant who received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX 40, CD137), and was discontinued from that treatment due to an immune-related adverse events. * Untreated or symptomatic brain metastases and leptomeningeal disease Note: participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. * Chronic intake of systemic corticosteroids (eg prednisone \> 10 mg/day or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. * Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine or insulin) is not considered a form of systemic treatment and is allowed. * History of organ transplantation. * History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * History of any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis. Other protocol-defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

colorectal neoplasm gastric neoplasm melanoma neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors

Contacts and locations

Locations

Alliance for Multispecialty Research - Kansas City

Merriam, Kansas, 66204, United States
Asan Medical Center

Seoul, 138-736, South Korea
City of Hope National Medical Center

Duarte, California, 91010, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Erasmus Medisch Centrum

Rotterdam, 3015 CE, Netherlands
Gustave Roussy

Villejuif, 94805, France
Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, 08036, Spain
Hospital Universitari Vall d Hebron

Barcelona, Catalonia, 08023, Spain
Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain
Institut Bergonie

Bordeaux, 33076, France
Istituto Oncologico della Svizzera Italiana

Bellinzona, 6500, Switzerland
Kantonsspital Sankt Gallen

Sankt Gallen, 9007, Switzerland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

Warsaw, 02-781, Poland
National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan
National Taiwan University Hospital

Taipei, 10002, Taiwan
Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1Z5, Canada
Radboud Universitair Medisch Centrum

Nijmegen, 6525 GA, Netherlands
Seoul National University Hospital

Seoul, 03080, South Korea
South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States
St Vincents Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia
Taipei Veterans General Hospital

Taipei, 11217, Taiwan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, 135-8550, Japan
The Queen Elizabeth Hospital

Woodville South, South Australia, 5011, Australia
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
Washington University

St Louis, Missouri, 63110, United States

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